Quality professional with 19 plus years of experience in the Biologics and Pharmaceutical Industry. Experience with facility design, start-up and commissioning, process validation, facilities and equipment qualification. Experienced with Regulatory Agency's such as FDA, WHO, OSHA and DEAIn-depth &valuable experience in all aspects related to Pharmaceutical/Biologics quality. Writing, executing and summarizing installation, operational and performance qualifications.Designed, reviewed and approved process validations. Quality System setup including designing cGMP compliant SOPs, validation protocols, product specifications and batch manufacturing records.Working knowledge of aseptic and sterile processing in vaccine manufacturing.Managed quality functions starting from raw material to finished products.Faced successful quality compliance audits from different agencies.Adept in change control, document approval, investigations and CAPA.Proficient in Quality control/Assurance of vaccines and Pharmaceutical solid dosage forms, strategic planning and resource management, technical troubleshooting, workforce supervision and customer relationship management processes.Adept in validation of analytical techniques with excellent documentation system including Validation protocols and reports.Excellent work planning, time management, communication skills, leadership, Quality & result oriented with the ability to work under pressure.Specialties: Establishing quality system in Pharmaceutical/Biopharmaceutical facility including facility qualification, IQ/OQ/PQ of equipment’s and systems used in Pharmaceuticals/Biopharmaceuticals, GMP trainings, GMP Audits and document control as per the cGMPs and FDA guidelines.